COMPARISON OF OXIDANT-ANTIOXIDANT LEVELS WITH STRESS HORMONES IN SPINAL ANESTHESIA AND GENERAL ANESTHESIA IN LAPAROSCOPIC TUBE LIGATION (LAP TUBE LİG)

The aim of this observational study is to investigate the effect of anesthesia method applied in laparoscopic tubal ligation on stress factors in women aged 15-45. The main question it aims to answer is:

Do spinal anesthesia and general anesthesia applied during laparoscopic tubal ligation surgery cause a change in the body's stress hormones? Do patients who undergo spinal anesthesia produce less oxidant-antioxidant than patients who undergo general anesthesia? Patients will answer the State and Trait Anxiety Scale questions before the operation

Study Overview

• Status: Enrolling by invitation
• Conditions: Gynecologic Laparoscopic Surgery

Detailed Description

Laparoscopic procedures are usually performed as day surgery. General and regional anesthesia; It is used successfully and safely when care is taken in the use of short-acting drugs, ensuring cardiovascular stability, rapid recovery and mobilization, postoperative nausea, vomiting and pain treatment.

Although the common procedure in laparoscopic surgeries is surgery under general anesthesia, it has been reported that regional anesthesia methods can be used safely within certain limits.

Regional anesthesia; It is advantageous due to rapid recovery, less nausea and vomiting and postoperative pain, short hospitalization, reduced cost, increased patient satisfaction, early diagnosis of complications and less hemodynamic changes. General anesthesia complications such as sore throat, muscle pain and airway trauma are not observed.

There are some limitations when regional anesthesia methods are applied in laparoscopic surgeries. Problems in the operating room cause the patient's anxiety, pain and discomfort to increase, causing the need for intravenous sedation support. Pneumoperitoneum effect may cause sedation, hypoventilation and decrease in arterial oxygen saturation.

One of the indications for regional anesthesia is laparoscopic tubal ligation. Procedures requiring many puncture points, important organ manipulations, steep inclination of the operating table, development of pneumoperitoneum make it difficult for the patient to breathe spontaneously and regional anesthesia should not be applied in these cases.

Spinal anesthesia is the simplest and most reliable regional anesthesia technique. Spinal anesthesia, which is a primary technique for laparoscopic gynecology, has many advantages over general anesthesia.

The patient position depends on the area to be operated on. In gynecological procedures, the Trendelenburg position is applied for the pelvic organs. In laparoscopic surgeries, the operator must be experienced in order to apply spinal anesthesia. Trendelenburg position may cause spinal block to spread to the head, increase sympathetic block, bradycardia and hypotension. In rare cases, intubation material and general anesthesia devices should be immediately available to ensure deep hypotension and respiratory continuity.

Regional anesthesia has advantages such as minimal effect on the respiratory system and prevention of the spread of pathogens related to intubation to the lower respiratory system.

Reduced thromboembolic complications and reduced surgical stress response. By using regional anesthesia techniques, aerosol-generating procedures can be avoided with less risk for healthcare personnel.

Low-dose spinal anesthesia is a good alternative to general anesthesia with desflurane in outpatient gynecological surgeries. Postoperative pain and cost are less in spinal anesthesia, while recovery is faster. When compared to general anesthesia with propofol total intravenous infusion, recovery time was found to be shorter in low-dose spinal anesthesia. With the development of gasless laparoscopy and microlaparoscopy techniques, the place of spinal anesthesia in laparoscopies will increase over time.

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06170
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female Adults Patients

Description

Inclusion Criteria:

• ASA I-II Women aged 18-45 Patients undergoing laparoscopic tubal ligation

Exclusion Criteria:

• Patients with psychiatric illness, Patients who developed complications during laparoscopy, Patients who converted from spinal anesthesia to general anesthesia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PATIENTS UNDERGOING LAPAROSCOPIC TUBA LIGATION SURGERY; COMPARISON OF PATIENTS UNDERGOING GENERAL AND SPINAL ANESTHESIA AS ANESTHESIA METHODS IN LAPAROSCOPIC TUBE LIGATION SURGERY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kortizol-acth levels	Determination of differences in cortisol and ACTH hormones in patients who underwent bilateral tubal ligation with spinal anesthesia compared to patients who underwent bilateral tubal ligation with general anesthesia.	from december 2024 to january 2025
oxidant-antioxidan levels	Determination of differences in oxidant-antioxidant values in patients who underwent bilateral tubal ligation with spinal anesthesia compared to patients who underwent bilateral tubal ligation with general anesthesia.	from december 2024 to january 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of patient and surgical satisfaction	Evaluation of patient and surgical satisfaction in patients undergoing bilateral tubal ligation with spinal anesthesia and in patients undergoing bilateral tubal ligation with general anesthesia	from january 2025 to february 2025

Collaborators and Investigators

• Sponsor: KADİR TEOMAN
• Collaborators: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: KADİR TEOMAN ETİKCAN, MEDİCAL DOCTOR, Ankara Etlik City Hospital

Publications and helpful links

General Publications

• Major AL, Jumaniyazov K, Yusupova S, Jabbarov R, Saidmamatov O, Mayboroda-Major I. Laparoscopy in Gynecologic and Abdominal Surgery in Regional (Spinal, Peridural) Anesthesia, the Utility of the Technique during COVID-19 Pandemic. Medicines (Basel). 2021 Oct 19;8(10):60. doi: 10.3390/medicines8100060.
• Kaya Ugur B, Pirbudak L, Ozturk E, Balat O, Ugur MG. Spinal versus general anesthesia in gynecologic laparoscopy: A prospective, randomized study. Turk J Obstet Gynecol. 2020 Sep;17(3):186-195. doi: 10.4274/tjod.galenos.2020.28928. Epub 2020 Oct 2.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 10, 2025
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 26, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: general anesthesia; spinal anesthesia; cortisol; acth; native thiol; total thiol; disulfide
• Other Study ID Numbers: AEŞH-EK1-2023-478

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No